a study of pediatric participants with attention deficit/hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the primary purpose of the study is to assess long-term safety and tolerability of edivoxetine in pediatric participants with attention deficit hyperactive disorder (adhd).


Eligibility criteria:
inclusion criteria: -participants must meet diagnostic and statistical manual of mental disorders 4th ed (dsm-iv) diagnostic criteria for adhd (inattentive, hyperactive/impulsive, or combined subtypes) based on an interview by an experienced clinician and confirmed using the kiddie schedule for affective disorders and schizophrenia for school aged children-present (sads) and lifetime version (k-sads-pl) at visit 1 for new participants and in the parent trial for rollover participants. -participants must have an adhdrs-iv-parent: inv total score of at least 1.5 standard deviations above the age/gender norm at both screening/randomization. new participants must have a clinical global impressions-attention-deficit/hyperactivity disorder- severity (cgi-adhd-s) score greater than or equal to 4 at both screening/randomization. * participants of child-bearing potential agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug. female participants of child-bearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test. * participants must have laboratory results, showing no clinically significant abnormalities. * parents/participants must have a degree of understanding sufficient to communicate suitably with the investigator/ study coordinator. * participants must be of normal intelligence. * participants/parents must have been judged by the investigator to be reliable to keep appointments for clinic visits/all tests, including venipunctures and examinations required by the protocol. * participants must be able to swallow tablets. exclusion criteria: * participants who weigh less than 16 kg at screening/randomization. * female participants who are pregnant/breastfeeding. * participants who have previously withdrawn/discontinued early from this study or any other study investigating edivoxetine. * participants who have a history of bipolar i/ii disorder, psychosis, or pervasive developmental disorder. * participants with a history of any seizure disorder or known electroencephalographic (eeg) abnormalities in the absence of seizures. * participants who are at serious suicidal risk. * participants with a history of severe allergies to more than 1 class of medications, or multiple adverse drug reactions, or known hypersensitivity to edivoxetine. * participants with a history of alcohol or drug abuse/dependence within the past 3 months of screening, or who are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner that the investigator considers indicative of abuse/dependence. * participants who screen positive for drugs of abuse cannot participate. * participants who have a medical condition that would increase sympathetic nervous system activity markedly, or who are taking a medication on a daily basis that has sympathomimetic activity are excluded. * participants with problems that would be exacerbated by increased norepinephrine tone including a history of cardiovascular disease, thyroid dysfunction, glaucoma, or urinary retention. * participants who at any time during the study are likely to need psychotropic medications apart from the drugs under study. * participants who have used a monoamine oxidase inhibitor (maoi) during the 2 weeks prior to randomization. * participants with current or past history of clinically significant hypertension. * participants who are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. * participants whose family anticipates a move outside the geographic range of the investigative site during participation in the study or who plan extended travel inconsistent with the recommended visit intervals. * participants who, in the opinion of the investigator, are unsuitable in any other way to participate in this study.